Ultrasonic guided ablation equipment

Abstract

The invention relates to the technical field of ultrasonic equipment, in particular to ultrasonic guided ablation equipment which comprises a composite ultrasonic transducer assembly and an equipment body, and the composite ultrasonic transducer assembly sends ultrasonic waves to a to-be-ablated area according to excitation signals and receives echo signals of the ultrasonic waves; the equipment main body comprises an imaging guide module, an excitation signal generation module and a control module, the imaging guide module is in signal connection with the composite ultrasonic transducer assembly, and the imaging guide module sends an excitation signal to the composite ultrasonic transducer assembly and receives an echo signal of the excitation signal to generate an image; the control module is in signal connection with the imaging guide module and the excitation signal generation module, the control module generates and obtains ablation parameters according to the image, and the ablation parameters control the size of the to-be-ablated area and the tissue denaturation degree; and the excitation signal generation module is in signal connection with the composite ultrasonic transducer assembly. The imaging guide module is matched with the excitation signal generation module, so that the safety and accuracy of the ultrasonic guide ablation equipment during use are improved.

Description

Technical Field

[0001] This application relates to the technical field of ultrasonic devices, and more particularly to an ultrasonic guided ablation device. Background Art

[0002] Ultrasound is an effective energy source for treating the skin, which can penetrate deep into the skin and reach the fascia layer. By using ultrasonic heads of different specifications, ultrasonic waves can be accurately focused on skin tissues at different depths, generating sufficient heat at the focal point, with the temperature reaching 50 - 75°C, thereby causing denaturation of skin tissues (epidermis, dermis, fascia, etc.) and activating collagen proliferation and remodeling. Whether it acts on the fat layer or the fascia layer, it has good usage effects.

[0003] However, when the current conventional ultrasonic guided ablation device uses ultrasonic waves to treat the skin, it cannot effectively obtain the position of the treated area and the tissue denaturation condition, resulting in the inability to accurately control the ablation energy, treatment position, and ablation time of ultrasonic treatment. Too small ablation energy or too short ablation time will lead to insignificant treatment effects, while too large ablation energy or too long ablation time will cause serious ultrasonic damage to the treated area, making it difficult to guarantee its safety and effectiveness. Summary of the Invention

[0004] This application mainly provides an ultrasonic guided ablation device, which can improve the safety and accuracy of the ultrasonic guided ablation device.

[0005] To solve the above technical problems, one technical solution adopted in this application is: to provide an ultrasonic guided ablation device including a composite ultrasonic transducer assembly and a device main body. The composite ultrasonic transducer assembly is configured to send ultrasonic waves to the ablation area to be treated according to an excitation signal and receive the echo signal of the ultrasonic waves; the device main body includes an imaging guidance module, an excitation signal generation module, and a control module. The imaging guidance module is signal - connected to the composite ultrasonic transducer assembly. The imaging guidance module is configured to send the excitation signal to the composite ultrasonic transducer assembly and receive the echo signal of the excitation signal for generating an image; the control module is signal - connected to the imaging guidance module and the excitation signal generation module. The control module is configured to generate and obtain ablation parameters based on the image, and the ablation parameters are used to control the size of the ablation area to be treated and the degree of tissue denaturation; the excitation signal generation module is signal - connected to the composite ultrasonic transducer assembly, and the excitation signal generation module is configured to generate and send the excitation signal to the composite ultrasonic transducer assembly according to the ablation parameters.

[0006] In a specific embodiment, the excitation signal includes a first excitation signal and a second excitation signal; the composite ultrasonic transducer assembly includes a micro-array imaging transducer and a single-element power transducer connected coaxially. The micro-array imaging transducer is configured to emit ultrasonic waves to the ablation area according to the first excitation signal and receive the echo signal. The single-element power transducer is configured to emit and focus the ultrasonic waves to the ablation area according to the second excitation signal. The imaging guidance module is signal-connected to the micro-array imaging transducer, and the imaging guidance module is configured to send the first excitation signal to the micro-array imaging transducer. The excitation signal generation module is signal-connected to the single-element power transducer, and the excitation signal generation module is configured to generate and send the second excitation signal to the single-element power transducer according to the ablation parameters.

[0007] In a specific embodiment, the imaging guidance module includes an ultrasonic excitation signal transmitting circuit, an echo receiving circuit, and a high-speed signal acquisition and processing circuit. The ultrasonic excitation signal transmitting circuit is signal-connected to the micro-array imaging transducer and is configured to generate the first excitation signal and send it to the micro-array imaging transducer. The echo receiving circuit is configured to receive and perform at least one of the processes such as amplifying, filtering, and denoising the echo signal. The high-speed signal acquisition and processing circuit is signal-connected to the control module, and the high-speed signal acquisition and processing circuit is configured to convert the processed echo signal into echo data and send it to the control module.

[0008] In a specific embodiment, the excitation signal generation module includes a pulse signal generation circuit and a power amplifier. The pulse signal generation circuit is signal-connected to the control module, and the pulse signal generation circuit is configured to generate a pulse signal according to the ablation parameters. The power amplifier is signal-connected to the control module and the single-element power transducer, and the power amplifier is configured to process the pulse signal to obtain the second excitation signal and send it to the single-element power transducer.

[0009] In a specific embodiment, the micro-array imaging transducer includes a linear array or a phased array. The number of elements of the linear array or the phased array is 4 to 128. The element length of the linear array or the phased array is 2 mm to 15 mm. The element width of the linear array or the phased array is 1 mm to 10 mm. The operating frequency range is 1 MHz to 40 MHz; and / or, the operating frequency range of the single-element power transducer is 100 kHz to 20 MHz, and the transmitted acoustic power is 100 mW to 70 W.

[0010] In a specific embodiment, the composite ultrasonic transducer assembly further includes a housing assembly, a partition board, and a circuit assembly. The circuit assembly is connected to the microarray imaging transducer and the imaging guidance module, and the circuit assembly is connected to the single-element power transducer and the excitation signal generation module. The housing assembly is provided with a sealed cavity. The partition board is disposed in the sealed cavity and divides the sealed cavity into a first cavity and a second cavity. The circuit assembly is accommodated in the first cavity, and the microarray imaging transducer and the single-element power transducer are disposed in the second cavity. The single-element power transducer is provided with a central through hole, and the microarray imaging transducer is disposed in the central through hole. The second cavity is further configured to accommodate an acoustic coupling liquid, and the acoustic coupling liquid is used to reduce the transmission loss of ultrasonic waves.

[0011] In a specific embodiment, the partition board is provided with a liquid injection hole, and the liquid injection hole communicates the first cavity and the second cavity. The liquid injection hole is used to inject the acoustic coupling liquid. The composite ultrasonic transducer assembly further includes an acoustic membrane. The housing assembly is provided with an acoustic hole, and the acoustic hole communicates the second cavity with the outside, and the acoustic hole is located at an end of the second cavity away from the partition board. The acoustic membrane seals the acoustic hole.

[0012] In a specific embodiment, the control module is configured to generate and obtain ablation parameters based on the image, including: the control module dynamically adjusts the ablation parameters according to the tissue denaturation region in the image, and the ablation parameters include ablation energy and ablation time.

[0013] In a specific embodiment, the ultrasonic guidance ablation device further includes a monitoring and protection module connected to the control module. The monitoring and protection module is configured to collect voltage, current, and temperature data, and trigger a power-off protection in case of overvoltage, overcurrent, or short circuit; and / or, the ultrasonic guidance ablation device further includes a human-machine interaction module connected to the control module. The human-machine interaction module is configured to display the ablation parameters and the monitoring results obtained by the control module based on the image.

[0014] In a specific embodiment, the ultrasonic guidance ablation device further includes a device identification module connected to the excitation signal generation module. The composite ultrasonic transducer assembly is detachably connected to the device main body. The composite ultrasonic transducer assembly further includes an identification tag. The device identification module reads the identification tag through the excitation signal generation module to obtain the mode, model information, and / or remaining usage times of the device.

[0015] The beneficial effects of the present application are as follows: Different from the prior art, in the embodiments of the present application, the imaging guidance module is used to obtain the image of the ablation target area, and the control module can adjust the excitation signal emitted by the excitation signal generation module according to the image of the ablation target area, so as to form a closed-loop control logic of ultrasound ablation - image feedback - parameter adjustment. Through the intelligent matching of image feature extraction and ablation parameters, the dynamic adjustment of ultrasound intensity and action time is realized. It can not only accurately determine the position where ultrasonic ablation needs to be performed, but also effectively control the ablation situation of the ablation target area, thereby improving the accuracy and safety of the operation of the composite ultrasonic transducer assembly, and greatly improving the usability of the ultrasound-guided ablation device. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings required for the description of the embodiments. Obviously, the following drawings are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0017] Figure 1 is a schematic block diagram of the structure of the ultrasound-guided ablation device provided by the present application;

[0018] Figure 2 is a schematic block diagram of the structure of the composite ultrasonic transducer, imaging guidance module and excitation signal generation module provided by the present application;

[0019] Figure 3 is a schematic assembly structure diagram of the ultrasound-guided ablation device provided by the present application;

[0020] Figure 4 is a schematic assembly structure diagram of the composite ultrasonic transducer assembly provided by the present application;

[0021] Figure 5 is Figure 4 the cross-sectional structure diagram of the A-A section in;

[0022] Figure 6 is Figure 5 the exploded structure diagram of some structures in;

[0023] Figure 7 is a schematic flow chart of the working process of an ultrasound-guided ablation device in an embodiment of the present application;

[0024] Figure 8 are multiple target area sonograms during the process of the ultrasound-guided ablation device provided by the embodiment of the present application treating ex vivo pork.

[0025] Reference Signs:

[0026] 1. Ultrasonic-guided ablation device; 2. Composite ultrasonic transducer assembly; 21. Microarray imaging transducer; 22. Single-element power transducer; 23. Housing assembly; 231. First cavity; 232. Second cavity; 233. Outer housing; 234. Inner housing; 235. Outer locking sleeve; 236. Inner locking sleeve; 237. Inner cover; 238. Outer cover; 239. Gasket; 24. Isolation plate; 241. Liquid injection hole; 242. Liquid injection plug; 25. Circuit assembly; 26. Wire terminal block; 26. Sound conduction hole; 261. Clamping part; 262. Abutting part; 27. Sound conduction film; 29. Transducer bracket; 3. Device main body; 31. Imaging guidance module; 311. Ultrasonic excitation signal transmitting circuit; 312. Echo receiving circuit; 313. High-speed signal acquisition and processing circuit; 32. Excitation signal generating module; 321. Pulse signal generating circuit; 322. Power amplifier; 33. Control module; 34. Monitoring and protection module; 35. Human-computer interaction module; 36. Device identification module. Detailed implementation manners

[0027] The present application will be further described in detail below in conjunction with the accompanying drawings and implementation manners. It should be specifically noted that the following implementation manners are only used to illustrate the present application, but do not limit the scope of the present application. Similarly, the following implementation manners are only some implementation manners of the present application rather than all implementation manners. All other implementation manners obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present application.

[0028] The terms "first", "second", and "third" in the present application are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first", "second", and "third" may explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined. All directional indications (such as up, down, left, right, front, back...) in the implementation manners of the present application are only used to explain the relative position relationship and movement conditions between components in a specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indications will also change accordingly. In addition, the terms "comprise" and "have" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally further include steps or units not listed, or may optionally further include other steps or units inherent to these processes, methods, products, or devices.

[0029] References herein to "embodiments" mean that the particular features, structures, or characteristics described in connection with the embodiments can be included in at least one embodiment of the present application. The phrase appears in various places in the specification and does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment mutually exclusive with other embodiments. Those skilled in the art will explicitly and implicitly understand that the embodiments described herein can be combined with other embodiments.

[0030] Ultrasound is an effective energy source for treating the skin, which can penetrate deep into the skin and reach the fascia layer. Through ultrasonic heads of different specifications, ultrasonic waves can be accurately focused on skin tissues at different depths, generating sufficient heat at the focal point, with the temperature reaching 50 - 75 °C, thereby causing denaturation of skin tissues (epidermis, dermis, fascia, etc.) and activating collagen proliferation and remodeling. Whether it acts on the fat layer or the fascia layer, it has good usage effects.

[0031] However, when the current conventional ultrasound-guided ablation device uses ultrasonic waves to ablate the skin, it cannot effectively obtain the position of the ablated area and the tissue denaturation situation, resulting in the inability to accurately control the ablation energy, ablation position, and ablation time of ultrasound ablation. If the ablation energy is too small or the ablation time is too short, the ablation effect will not be significant. If the ablation energy is too large or the ablation time is too long, the ablated area will be severely damaged by ultrasound, and its safety and effectiveness are difficult to guarantee.

[0032] In order to improve or solve the above technical problems, the inventors of the present application have conducted long-term research and proposed at least the following embodiments.

[0033] Refer to Figures 1 to 6 , Figure 1 which is a structural schematic block diagram of the ultrasound-guided ablation device provided by the present application. Figure 2 which is a structural schematic block diagram of the composite ultrasonic transducer, imaging guidance module, and excitation signal generation module provided by the present application. Figure 3 which is an assembly structure schematic diagram of the ultrasound-guided ablation device provided by the present application. Figure 4 which is an assembly structure schematic diagram of the composite ultrasonic transducer assembly provided by the present application. Figure 5 which is Figure 4 the sectional structure schematic diagram of the A - A section in Figure 6 which is Figure 5 the exploded structure schematic diagram of part of the structure in

[0034] To solve the above technical problems, a specific embodiment of the present application provides an ultrasonic-guided ablation device 1 for ablating a region to be ablated using ultrasonic waves. The ultrasonic-guided ablation device 1 may include a composite ultrasonic transducer assembly 2 and a device body 3. The composite ultrasonic transducer assembly 2 is configured to send ultrasonic waves to the region to be ablated according to an excitation signal and receive the echo signal of the ultrasonic waves. The device body 3 may include an imaging guidance module 31, an excitation signal generation module 32, and a control module 33. The imaging guidance module 31 is signal-connected to the composite ultrasonic transducer assembly 2. The imaging guidance module 31 is configured to send an excitation signal to the composite ultrasonic transducer assembly 2 and receive an ablation echo signal so that the ablation echo signal can be used to generate an image.

[0035] The control module 33 is signal-connected to the imaging guidance module 31 and the excitation signal generation module 32. The control module 33 is configured to generate an image and can obtain ablation parameters based on the image. These ablation parameters can be used to control the size of the region to be ablated and the degree of tissue denaturation. The excitation signal generation module 32 is signal-connected to the composite ultrasonic transducer assembly 2. The excitation signal generation module 32 is configured to generate an excitation signal according to the ablation parameters and send the excitation signal to the composite ultrasonic transducer assembly 2.

[0036] In the structure provided by this specific embodiment, the imaging guidance module 31 is used to obtain an image of the region to be ablated. The control module 33 can adjust the excitation signal sent by the excitation signal generation module 32 according to the image of the region to be ablated, thereby forming a closed-loop control logic of ultrasonic ablation - image feedback - parameter adjustment. Through the intelligent matching of image feature extraction and ablation parameters, the dynamic adjustment of ultrasonic intensity and action time is realized. It can not only accurately determine the position where ultrasonic ablation needs to be performed, but also effectively control the ablation situation of the region to be ablated, thereby improving the accuracy and safety of the operation of the composite ultrasonic transducer assembly 2 and greatly enhancing the usability of the ultrasonic-guided ablation device 1.

[0037] In a specific embodiment of the present application, the excitation signal may include a first excitation signal and a second excitation signal. The composite ultrasonic transducer assembly 2 may include a microarray imaging transducer 21 and a single-element power transducer 22 connected coaxially. The microarray imaging transducer 21 is configured to emit ultrasonic waves to the region to be ablated according to the first excitation signal and can receive the echo signal of the ultrasonic waves. The single-element power transducer 22 is configured to emit focused ultrasonic waves to the region to be ablated according to the second excitation signal.

[0038] The imaging guidance module 31 is signal-connected to the microarray imaging transducer 21, and the imaging guidance module 31 is configured to send a first excitation signal to the microarray imaging transducer 21. The excitation signal generation module 32 is signal-connected to the single-element power transducer 22, and the excitation signal generation module 32 is configured to generate a second excitation signal according to the ablation parameters and send the second excitation signal to the single-element power transducer 22.

[0039] In the structure provided in this specific embodiment, the first excitation signal is used to prompt the microarray imaging transducer 21 to acquire an image of the ablation target area. The second excitation signal is formed based on the feedback of the image, and can prompt the single-element power transducer 22 to ablate the ablation target area under the guidance of the image, so that the position where ultrasonic ablation needs to be performed can be accurately determined, and the ablation condition of the ablation target area can be effectively controlled, greatly improving the accuracy and safety of the operation of the composite ultrasonic transducer assembly 2.

[0040] Figure 8 These are the sonograms of multiple target areas during the ablation experiment of ex vivo pork by the ultrasonic guidance ablation device provided in the embodiment of the present application. Figure 8 It includes a total of four sonograms of the same area on the ex vivo pork obtained at different times. The four sonograms of the target area are arranged from left to right in the chronological order of the ablation process. It is not difficult to find that as the duration of ultrasonic ablation increases, the high echo areas in the sonograms of the target area obtained by the ultrasonic guidance ablation device gradually increase, indicating that the areas where tissue degeneration is caused by ultrasonic ablation in this area gradually increase. The ablation condition of the ablation target area can be clearly understood through the change of the sonogram of the target area, so as to further effectively control the ablation condition of the ablation target area.

[0041] In a specific embodiment of the present application, the imaging guidance module 31 may specifically include an ultrasonic excitation signal transmitting circuit 311, an echo receiving circuit 312, and a high-speed signal acquisition and processing circuit 313. The ultrasonic excitation signal transmitting circuit 311 is signal-connected to the microarray imaging transducer 21, and the ultrasonic excitation signal transmitting circuit 311 is configured to generate a first excitation signal and send it to the microarray imaging transducer 21. The echo receiving circuit 312 is signal-connected to the microarray imaging transducer 21, and the echo receiving circuit 312 is configured to receive and perform at least one of the processes of amplifying, filtering, and denoising the echo signal. The high-speed signal acquisition and processing circuit 313 is signal-connected to the control module 33, and the high-speed signal acquisition and processing circuit 313 is configured to convert the processed echo signal into echo data and send it to the control module 33.

[0042] Among them, the ultrasonic excitation signal transmitting circuit 311 can generate multi-channel high-voltage pulse electrical signals. The transmitted pulse sequence is output by a programmable logic device (FPGA), and the basic parameters including frequency, number, delay, duty cycle, repetition frequency, timing, etc. can all be programmed and controlled. In order to emit multi-channel high-voltage pulse electrical signals, the ultrasonic excitation signal transmitting circuit 311 can include a transmitting power amplifier 322. The transmitting power amplifier 322 is implemented by a field-effect transistor driver and a field-effect transistor pair, with two pairs of push-pull circuits integrated inside. The front-end logic controls and drives the gate to conduct a high-voltage excitation of up to ±100V. The matching circuit consists of a series resistor and a parallel inductor, and is fine-tuned according to the actual spectral characteristics of the transducer to achieve matching, and finally generates multi-channel high-voltage pulse electrical signals.

[0043] Optionally, since the echo signal received by the echo receiving circuit 312 is very weak and needs to be amplified, the echo receiving circuit 312 can be composed of a transceiver isolation circuit, a variable gain amplifier, a filtering circuit, and an analog-to-digital conversion circuit. A transceiver switching switch is designed at the very front end of the echo receiving circuit 312, which is disconnected at the moment of the excitation high voltage and then conducts to receive the echo signal after the transmission is completed, so that the echo signal can enter the subsequent high-speed signal acquisition and processing circuit 313 without loss through the diode.

[0044] Optionally, after the signal is amplified by the variable gain amplifier and analog-filtered by the filtering circuit, the high-speed signal acquisition and processing circuit 313 can perform analog-to-digital conversion on the ultrasonic echo, and implement functions such as register configuration, large-capacity data caching, time gain compensation, and beamforming algorithm. The control module 33 can read the received echo data, and obtain a two-dimensional gray-scale ultrasonic image through signal modulation and low-pass filtering, data decimation, data logarithmic enhancement, data line rearrangement, interpolation reconstruction, etc.

[0045] In the structure provided by this specific embodiment, the imaging guidance module 31 uses the ultrasonic excitation signal transmitting circuit 311 to send a first excitation signal to the microarray imaging transducer 21, uses the echo receiving circuit 312 to receive and process the echo signal of the first excitation signal, and finally uses the high-speed signal acquisition and processing circuit 313 to convert the processed echo signal into digital echo data, enabling the control module 33 to read the echo data, thereby accurately knowing the situation of the area to be ablated, and further improving the accuracy of adjusting the second excitation signal, and enhancing the accuracy and safety of the operation of the composite ultrasonic transducer assembly 2.

[0046] In a specific embodiment of the present application, the excitation signal generation module 32 includes a pulse signal generation circuit 321 and a power amplifier 322. The pulse signal generation circuit 321 is signal-connected to the control module 33, and the pulse signal generation circuit 321 is configured to generate a pulse signal according to the ablation parameters. The power amplifier 322 is signal-connected to the control module 33 and the single-element power transducer 22, and the power amplifier 322 is configured to process the pulse signal to obtain a second excitation signal and send it to the single-element power transducer 22.

[0047] In the structure provided by this specific embodiment, the pulse signal generation circuit 321 can generate a corresponding pulse signal according to the ablation parameters, and the power amplifier 322 processes the pulse signal, so that a second excitation signal that meets the requirements can be obtained to perform more accurate and safe ablation on the area to be ablated.

[0048] Optionally, the pulse signal generation circuit 321 may specifically be a single-channel pulse signal generation circuit 321. The single-channel pulse signal generation circuit 321 is designed using a direct digital synthesizer (DDS) scheme, which mainly includes a reference frequency source, a phase accumulator, a data memory, a digital-to-analog converter, a low-pass filter, etc. The reference frequency source is a crystal oscillator. The phase accumulator accumulates at a certain step size. The pulse waveform function is stored in the data memory. The phase value output by the phase accumulator is used as an address to find the data of the waveform function in the lookup table, perform digital-to-analog conversion, and the output signal passes through a low-pass filter to generate a pulse sequence signal. Parameters such as the amplitude, frequency, number, delay, duty cycle, repetition frequency, and timing of the pulse signal can be configured. The power amplifier 322 may include a linear broadband power amplifier 322. The processing performed by the power amplifier 322 on the pulse signal may specifically be power amplification processing, and after power amplification, it can be output to an impedance matching circuit to generate a high-voltage pulse electrical signal as the second excitation signal.

[0049] In a specific embodiment of the present application, the microarray imaging transducer 21 includes a linear array or a phased array. The number of elements in the linear array or phased array is 4 to 128, the element length of the linear array or phased array is 2 mm to 15 mm, the element width of the linear array or phased array is 1 mm to 10 mm, and the operating frequency includes 1 MHz to 40 MHz. The pulse length of the microarray imaging transducer 21 can be between 10 μs and 500 ms, the number of pulses is between 4 and 64, and the repetition frequency can be between 10 Hz and 1000 Hz. Optionally, the microarray imaging transducer 21 has a length between 2 and 15 millimeters, a width between 1 and 10 millimeters, and is arranged facing the area to be ablated.

[0050] Optionally, a single-element ultrasonic transducer is used to ablate the area to be ablated, and its contour shape can be a circular concave shape with a central opening. The operating frequency of the single-element power transducer 22 ranges from 100 kHz to 20 MHz, and the transmitted acoustic power is from 100 mW to 70 W.

[0051] Optionally, the diameter of the single-element power transducer 22 can be 5 - 35 mm, the pulse length is between 10 us and 500 ms, the number of pulses is between 4 and 64, the repetition frequency is between 1 Hz and 1000 Hz, and the output acoustic power is between 100 mW and 70 W.

[0052] The array elements of transducers such as the microarray imaging transducer 21 and the single-element power ultrasonic transducer can be designed as a multi-layer stack structure, mainly composed of an acoustic lens, a matching layer, a piezoelectric material layer, an electrode layer, a backing layer, and a heat dissipation layer. The acoustic lens is located on the surface of the transducer to protect the piezoelectric material layer from being worn or damaged. It is made of silicone rubber, has an acoustic impedance similar to that of the area to be ablated, and has low attenuation. It is used for beam focusing and can improve the lateral resolution. The matching layer is made of epoxy resin and dense powder (such as alumina, glass powder, etc.) to solve the acoustic matching between the acoustic impedance of the transducer and that of biological tissue and enhance the ultrasonic energy transmitted into the tissue. The piezoelectric material layer can be made of at least one of materials such as ceramics, polymers, metals, and composite materials, and has a unique piezoelectric effect, enabling the mutual conversion of electrical signals and acoustic signals. It is the core component of the transducer. The electrode layer is made of metal and can be at least one of stainless steel, copper, gold, silver, platinum, nitinol, or other conductive materials.

[0053] The backing layer is prepared using epoxy resin, tungsten powder, alumina powder, and some additives to enhance attenuation. It has acoustic characteristics of high attenuation and low acoustic impedance, absorbs the acoustic energy radiated inward by the piezoelectric material layer due to vibration, prevents interference caused by acoustic energy reflection, connects the piezoelectric material layer and the heat dissipation layer, and conducts heat from the piezoelectric material layer to the heat dissipation layer. The heat dissipation layer is made of aluminum alloy, copper, copper alloy, and other metals and has high thermal conductivity. The microarray imaging transducer 21 is fixedly installed at the distal center position of the composite ultrasonic transducer assembly 2, coaxially placed with the single-element power ultrasonic transducer, facing its focused area to be ablated, and is attached to the epidermis at the area to be ablated during use. By individually leading wires for each array element, programmable electronic switch control, and time delay control, dynamic focusing imaging is achieved through the cooperation of multiple array elements to obtain a two-dimensional grayscale image of the skin tissue.

[0054] In the structure provided by this specific embodiment, by setting the adjustable parameter ranges of the microarray imaging transducer 21 and the single-element power ultrasonic transducer to meet the requirements for ablating the area to be ablated, the usability of the composite ultrasonic transducer assembly 2 can be maintained.

[0055] Refer to Figure 5 、Figure 6 , in a specific embodiment, the composite ultrasonic transducer assembly 2 may further include a housing assembly 23, a partition board 24, and a circuit assembly 25. The circuit assembly 25 is connected to the microarray imaging transducer 21 and the imaging guiding module 31, and the circuit assembly 25 is connected to the single-element power transducer 22 and the excitation signal generating module 32. The housing assembly 23 is provided with a sealed cavity, and the partition board 24 is disposed in the sealed cavity and divides the sealed cavity into a first cavity 231 and a second cavity 232. The circuit assembly 25 is accommodated in the first cavity 231, and the microarray imaging transducer 21 and the single-element power transducer 22 are disposed in the second cavity 232. The single-element power transducer 22 may be provided with a central through hole, and the microarray imaging transducer 21 is disposed in the central through hole. The second cavity 232 is also used to accommodate a sound guiding liquid, and the sound guiding liquid is used to reduce the transmission loss of ultrasonic waves.

[0056] In the structure provided by this specific embodiment, when the microarray imaging transducer 21 and the single-element power transducer 22 are working, the conduction effect of the sound guiding liquid can be utilized to reduce the transmission loss of ultrasonic waves, improve the working efficiency, and improve the usability of the composite ultrasonic transducer assembly 2. The partition board 24 can isolate the liquid sound guiding liquid from the circuit assembly 25, avoiding circuit problems such as poor contact, short circuit, and open circuit caused by the direct contact between the sound guiding liquid and the current assembly, and can improve the stability of the composite ultrasonic transducer assembly 2.

[0057] In a specific embodiment of the present application, the partition board 24 may specifically be provided with a liquid injection hole 241, and the liquid injection hole 241 communicates with the first cavity 231 and the second cavity 232, and the liquid injection hole 241 is used for injecting the sound guiding liquid. The composite ultrasonic transducer assembly 2 may further include a sound guiding film 27. The housing assembly 23 is provided with a sound guiding hole 26, and the sound guiding hole 26 communicates with the second cavity 232 and the outside, and the sound guiding hole 26 is located at one end of the second cavity 232 away from the partition board 24, and the sound guiding film 27 plugs the sound guiding hole 26.

[0058] In the structure provided by this specific embodiment, the sound guiding film 27 is used to isolate the second cavity 232 from the outside, and at the same time enable ultrasonic waves to be transmitted to the area to be ablated through the sound guiding hole 26 and the sound guiding film 27, so as to realize the ablation of the area to be ablated by using ultrasonic waves, or to image the area to be ablated by using ultrasonic waves.

[0059] Optionally, a liquid injection plug 242 may be provided for the liquid injection hole 241, and the liquid injection plug 242 can be inserted into and block the liquid injection hole 241, so as to realize the complete isolation of the first cavity 231 and the second cavity 232, and reduce the probability of the sound guiding liquid leaking into the first cavity 231.

[0060] Optionally, a transducer support 29 may also be provided in the second cavity 232. One end of the transducer support 29 is clamped and cooperated with the micro-array imaging transducer 21 and the single-element power transducer 22, and the other end of the transducer support 29 is fixed to the housing assembly 23 and / or the isolation plate 24, so as to fix the micro-array imaging transducer 21 and the single-element power transducer 22 in the second cavity 232, reduce the shaking of the micro-array imaging transducer 21 and the single-element power transducer 22, and improve the stability of the ultrasound-guided ablation device 1.

[0061] Referring to Figure 6 , the housing assembly 23 may specifically include an outer housing 233 and an inner housing 234. The housing assembly 23 may be made of polymer materials such as polycarbonate and polypropylene. The inner housing 234 may be provided with a resisting top 262, and the outer housing 233 is provided with a clamping portion 261. The outer housing 233 and the inner housing 234 are sleeved and connected. The outer periphery of the acoustic guiding film 27 is limited in the acoustic guiding hole 26 by the clamping portion 261, and the resisting top 262 abuts against the acoustic guiding film 27, so as to support the acoustic guiding film 27 to make it flat and reduce the loss of ultrasonic waves when transmitting through the acoustic guiding film 27. The acoustic guiding film 27 may be made of materials such as polycarbonate and polypropylene, and may be directly attached to the epidermis corresponding to the ablation area during the ablation process.

[0062] Optionally, the housing assembly may further include a gasket 239. The gasket 239 abuts between the inner housing 234 and the isolation plate 24, which can improve the sealing performance of the second cavity 232 and reduce the probability of acoustic guiding liquid leakage.

[0063] A wire connection base 251 may also be provided on the isolation plate 24. The wire connection base connects the wires of the circuit assembly 25 with the micro-array imaging transducer 21 and the single-element power transducer 22. The wires of the circuit assembly 25 may be connected to the device main body 3 for transmitting signals such as echo signals, first excitation signals, and second excitation signals.

[0064] Optionally, the housing assembly 23 may further include an outer locking sleeve 235, an inner locking sleeve 236, an inner cover 237, and an outer cover 238. The outer locking sleeve 235, the inner locking sleeve 236, the outer cover 238, and the inner cover 237 are fixedly connected. The inner cover 237 is connected to the isolation plate 24 and the wire connection base to form a first cavity 231 isolated from the outside world, which plays a protective role for the circuit assembly 25.

[0065] In a specific embodiment of the present application, the control module 33 is used to generate and obtain ablation parameters according to the image, including: the control module 33 dynamically adjusts the ablation parameters according to the tissue degeneration area in the image, and the ablation parameters include ablation energy and ablation time.

[0066] Among them, the control module 33 can compile the received control instructions and transmit them to each module in the composite ultrasonic transducer assembly 2, thereby realizing corresponding functions. The functions can include imaging ultrasonic excitation pulse control, echo signal processing control, imaging guidance control, treatment parameter calculation and analysis control, treatment ultrasonic excitation pulse control, etc.

[0067] As Figure 7 shown, Figure 7 This is a schematic block diagram of the working process of an ultrasonic guided ablation device in an embodiment of the present application. In this embodiment, the working process of the ultrasonic guided ablation device may include the following steps:

[0068] S100: The composite ultrasonic transducer assembly 2 is attached to the ablation area to be treated, and the control module 33, the imaging guidance module 31, and the microarray imaging transducer 21 inside the composite ultrasonic transducer assembly 2 are used to image the ablation area to be treated, and an image of the ablation area to be treated is obtained.

[0069] S200: According to the default ablation parameters, the excitation signal generation module 32 is controlled to generate a second excitation signal with corresponding frequency, pulse width, and amplitude to drive the single-element power transducer 22 inside the composite ultrasonic transducer assembly 2 to accurately focus on the ablation areas to be treated at different depths, and a high temperature of 50 - 15 °C is generated at the focal point, generating a coagulation point in the skin tissue and causing collagen denaturation.

[0070] S300: The control module 33, the imaging guidance module 31, and the microarray imaging transducer 21 inside the composite ultrasonic transducer assembly 2 are used to image the ablation area to be treated again, and the position of the ablation area to be treated after ablation, the tissue denaturation area (effective ablation area), and the tissue denaturation situation are displayed and monitored.

[0071] S400: The control module 33 is used to adjust the ablation parameters, including ablation energy and ablation time, and the excitation signal generation module 32 and the single-element power transducer 22 cooperate to control the size of the next ablation of the ablation area to be treated and the degree of tissue denaturation, so as to achieve precise and effective ablation.

[0072] In a specific embodiment of the present application, the ultrasonic guided ablation device 1 may further include a monitoring and protection module 34, and the monitoring and protection module 34 is connected to the control module 33. The monitoring and protection module 34 is used to collect voltage, current, and temperature data, and can trigger power-off protection in case of overvoltage, overcurrent, or short circuit, improving the stability and safety of the ultrasonic guided ablation device 1.

[0073] Optionally, the ultrasonic guided ablation device 1 may further include a human-machine interaction module 35, the human-machine interaction module 35 is connected to the control module 33, and the human-machine interaction module 35 can be used to display ablation parameters and the monitoring results obtained by the control module 33 according to the images.

[0074] The human-machine interaction module 35 may include a display screen and buttons. The display screen can display the startup status of the ultrasonic guided ablation device 1, the information of the composite ultrasonic transducer assembly 2, the functional status of the composite ultrasonic transducer assembly 2, etc. The buttons can be used to control the startup and shutdown of the ultrasonic guided ablation device 1, select the imaging mode of the composite ultrasonic transducer assembly 2, select the treatment mode of the composite ultrasonic transducer assembly 2, turn on the imaging function of the composite ultrasonic transducer assembly 2, turn on the treatment function of the composite ultrasonic transducer assembly 2, and operate the handle to control the number of pulse emissions, etc.

[0075] In a specific embodiment of the present application, the ultrasonic guided ablation device 1 may further include a device identification module 36. The device identification module 36 is connected to the excitation signal generation module 32, and the composite ultrasonic transducer assembly 2 is detachably connected to the device main body 3. The composite ultrasonic transducer assembly 2 may further include an identification label, and the device identification module 36 reads the identification label through the excitation signal generation module 32 to obtain the mode, model information and / or remaining usage times of the composite ultrasonic transducer assembly 2. In the structure provided by this specific embodiment, the mode, model information and remaining usage times of the composite ultrasonic transducer assembly 2 can be recorded by using the identification label, which can improve the usability of the ultrasonic guided ablation device 1.

[0076] The ultrasonic guided ablation device 1 may further include a power supply, and the power supply may include a DC power supply and a power management module, and the power supply can stably supply power to each module.

[0077] The above are only some embodiments of the present application, and thus do not limit the protection scope of the present application. Any equivalent device or equivalent process transformation made by using the content of the specification and drawings of the present application, or directly or indirectly applied in other related technical fields, shall be similarly included in the patent protection scope of the present application.

Claims

1. An ultrasonic guided ablation device, characterized in that, Comprising: A composite ultrasonic transducer assembly (2) for transmitting ultrasonic waves to the ablation region to be treated according to an excitation signal and receiving the echo signal of the ultrasonic waves; A device body (3) including an imaging guidance module (31), an excitation signal generation module (32), and a control module (33). The imaging guidance module (31) is signal-connected to the composite ultrasonic transducer assembly (2). The imaging guidance module (31) is configured to transmit the excitation signal to the composite ultrasonic transducer assembly (2) and receive the echo signal of the excitation signal for generating an image. The control module (33) is signal-connected to the imaging guidance module (31) and the excitation signal generation module (32). The control module (33) is configured to generate ablation parameters based on and according to the image. The ablation parameters are used to control the size of the ablation region to be treated and the degree of tissue denaturation. The excitation signal generation module (32) is signal-connected to the composite ultrasonic transducer assembly (2). The excitation signal generation module (32) is configured to generate and transmit the excitation signal to the composite ultrasonic transducer assembly (2) according to the ablation parameters.

2. The ultrasound-guided ablation device according to claim 1, characterized in that, The excitation signal includes a first excitation signal and a second excitation signal; The composite ultrasonic transducer assembly (2) includes a microarray imaging transducer (21) and a single-element power transducer (22) connected coaxially. The microarray imaging transducer (21) is configured to transmit ultrasonic waves to the ablation region to be treated according to the first excitation signal and receive the echo signal. The single-element power transducer (22) is configured to transmit and focus the ultrasonic waves to the ablation region to be treated according to the second excitation signal; The imaging guidance module (31) is signal-connected to the microarray imaging transducer (21). The imaging guidance module (31) is configured to transmit the first excitation signal to the microarray imaging transducer (21); The excitation signal generation module (32) is signal-connected to the single-element power transducer (22). The excitation signal generation module (32) is configured to generate and transmit the second excitation signal to the single-element power transducer (22) according to the ablation parameters.

3. The ultrasound-guided ablation device according to claim 2, wherein, The imaging guidance module (31) includes: An ultrasonic excitation signal transmitting circuit (311), signal-connected to the microarray imaging transducer (21), for generating the first excitation signal and transmitting it to the microarray imaging transducer (21); An echo receiving circuit (312) for receiving and performing at least one of processing such as amplifying, filtering, and denoising on the echo signal; A high-speed signal acquisition and processing circuit (313), signal-connected to the control module (33). The high-speed signal acquisition and processing circuit (313) is configured to convert the processed echo signal into echo data and transmit it to the control module (33).

4. The ultrasound-guided ablation device according to claim 2, wherein The excitation signal generation module (32) includes: A pulse signal generation circuit (321), signal-connected to the control module (33). The pulse signal generation circuit (321) is configured to generate a pulse signal according to the ablation parameters; A power amplifier (322) is signal-connected to the control module (33) and the single-element power transducer (22). The power amplifier (322) is configured to process the pulse signal to obtain the second excitation signal and send it to the single-element power transducer (22).

5. The ultrasonic guidance ablation device according to claim 2, wherein the micro-array imaging transducer (21) includes a linear array or a phased array. The number of elements of the linear array or the phased array is 4 to 128. The element length of the linear array or the phased array is 2 mm to 15 mm. The element width of the linear array or the phased array is 1 mm to 10 mm. The operating frequency range is 1 MHz to 40 MHz; and / or, the operating frequency range of the single-element power transducer (22) is 100 kHz to 20 MHz, and the transmitted acoustic power is 100 mW to 70 W.

6. The ultrasonic guidance ablation device according to claim 2, wherein the composite ultrasonic transducer assembly (2) further includes a housing assembly (23), a partition board (24), and a circuit assembly (25). The circuit assembly (25) is connected to the micro-array imaging transducer (21) and the imaging guidance module (31). The circuit assembly (25) is connected to the single-element power transducer (22) and the excitation signal generation module (32); the housing assembly (23) is provided with a sealed cavity. The partition board (24) is disposed in the sealed cavity and divides the sealed cavity into a first cavity (231) and a second cavity (232). The circuit assembly (25) is accommodated in the first cavity (231). The micro-array imaging transducer (21) and the single-element power transducer (22) are disposed in the second cavity (232). The single-element power transducer (22) is provided with a central through hole, and the micro-array imaging transducer (21) is disposed in the central through hole. The second cavity (232) is further configured to accommodate an acoustic guiding liquid, and the acoustic guiding liquid is used to reduce the transmission loss of ultrasonic waves.

7. The ultrasonic guidance ablation device according to claim 6, wherein the partition board (24) is provided with a liquid injection hole (241). The liquid injection hole (241) communicates the first cavity (231) and the second cavity (232), and the liquid injection hole (241) is used to inject the acoustic guiding liquid; the composite ultrasonic transducer assembly (2) further includes an acoustic guiding film (27). The housing assembly (23) is provided with an acoustic guiding hole (26). The acoustic guiding hole (26) communicates the second cavity (232) with the outside, and the acoustic guiding hole (26) is located at one end of the second cavity (232) away from the partition board (24). The acoustic guiding film (27) plugs the acoustic guiding hole (26).

8. The ultrasonic guidance ablation device according to any one of claims 1 to 7, wherein the control module (33) is configured to generate and obtain ablation parameters based on the image, including: The control module (33) dynamically adjusts ablation parameters according to the tissue degeneration region in the image, and the ablation parameters include ablation energy and ablation time.

9. The ultrasonic guidance ablation device according to any one of claims 1 to 7, characterized in that it further includes a monitoring and protection module (34), which is connected to the control module (33). The monitoring and protection module (34) is used for collecting voltage, current and temperature data, and triggering power-off protection in case of overvoltage, overcurrent or short circuit; and / or it further includes a human-computer interaction module (35), which is connected to the control module (33). The human-computer interaction module (35) is used for displaying the ablation parameters and the monitoring results obtained by the control module (33) according to the image.

10. The ultrasonic guided ablation device according to any one of claims 1 to 7, characterized in that, It further includes a device identification module (36), which is connected to the excitation signal generation module (32). The composite ultrasonic transducer assembly (2) is detachably connected to the device main body (3). The composite ultrasonic transducer assembly (2) further includes an identification label, and the device identification module (36) reads the identification label through the excitation signal generation module (32) to obtain the mode, model information and / or remaining usage times of the device.

Images